U.S. patent application number 17/190921 was filed with the patent office on 2021-09-09 for laser pulse shaping to enhance conversion efficiency and protect fiber optic delivery system for disruption of vascular calcium.
The applicant listed for this patent is Bolt Medical, Inc., Boston Scientific Scimed, Inc.. Invention is credited to Christopher A. Cook, Daniel Massimini, Roger McGowan, Haiping Shao.
Application Number | 20210275249 17/190921 |
Document ID | / |
Family ID | 1000005496746 |
Filed Date | 2021-09-09 |
United States Patent
Application |
20210275249 |
Kind Code |
A1 |
Massimini; Daniel ; et
al. |
September 9, 2021 |
LASER PULSE SHAPING TO ENHANCE CONVERSION EFFICIENCY AND PROTECT
FIBER OPTIC DELIVERY SYSTEM FOR DISRUPTION OF VASCULAR CALCIUM
Abstract
A catheter system includes a power source, a controller, and a
light guide. The power source generates a plurality of energy
pulses. The controller controls the power source so that the
plurality of energy pulses cooperate to produce a composite energy
pulse having a composite pulse shape. The light guide receives the
composite energy pulse. The light guide emits light energy in a
direction away from the light guide to generate a plasma pulse away
from the light guide. The power source can be a laser and the light
guide can be an optical fiber. Each of the energy pulses has a
pulse width, and the energy pulses are added to one another so that
the composite energy pulse has a pulse width that is longer than
the pulse width of any one of the energy pulses. At least two of
the energy pulses can have the same wavelength as or a different
wavelength from one another.
Inventors: |
Massimini; Daniel; (Brooklyn
Park, MN) ; McGowan; Roger; (Otsego, MN) ;
Shao; Haiping; (Plymouth, MN) ; Cook; Christopher
A.; (Laguna Niguel, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc.
Bolt Medical, Inc. |
Maple Grove
Carisbad |
MN
CA |
US
US |
|
|
Family ID: |
1000005496746 |
Appl. No.: |
17/190921 |
Filed: |
March 3, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62987060 |
Mar 9, 2020 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/00369
20130101; A61B 2018/266 20130101; A61B 2017/00159 20130101; A61B
2018/00702 20130101; A61B 2018/0022 20130101; A61B 18/26 20130101;
A61B 2018/00404 20130101; A61B 2017/00185 20130101; A61B 2018/00761
20130101 |
International
Class: |
A61B 18/26 20060101
A61B018/26 |
Claims
1. A catheter system for treating a treatment site within or
adjacent to a vessel wall or heart valve, the catheter system
comprising: a power source that generates a plurality of energy
pulses; a controller that controls the power source so that the
plurality of energy pulses cooperate to produce a composite energy
pulse having a composite pulse shape; and a light guide that
receives the composite energy pulse, the light guide emitting light
energy in a direction away from the light guide to generate a
plasma pulse away from the light guide.
2. The catheter system of claim 1 wherein the power source is a
laser.
3. The catheter system of claim 1 wherein the light guide is an
optical fiber.
4. The catheter system of claim 1 further comprising an inflatable
balloon that encircles a distal end of the light guide.
5. The catheter system of claim 1 wherein each of the energy pulses
has a pulse width, and the energy pulses are added to one another
so that the composite energy pulse has a pulse width that is longer
than the pulse width of any one of the energy pulses.
6. The catheter system of claim 1 wherein at least two of the
plurality of energy pulses have the same wavelength as one
another.
7. The catheter system of claim 1 wherein at least one of the
plurality of energy pulses has a wavelength that is different from
the other energy pulses.
8. The catheter system of claim 1 wherein at least two of the
plurality of energy pulses have pulse widths that are the same as
one another.
9. The catheter system of claim 1 wherein at least two of the
plurality of energy pulses have pulse widths that are different
from one another.
10. The catheter system of claim 1 wherein the plurality of energy
pulses combine to generate one continuous plasma pulse away from
the distal end of the light guide.
11. The catheter system of claim 1 wherein the composite energy
pulse has a pulse amplitude that increases over time.
12. The catheter system of claim 1 wherein the composite energy
pulse has a pulse amplitude that decreases over time.
13. The catheter system of claim 1 wherein the composite energy
pulse has a pulse width having a time t, the composite energy pulse
having a temporal peak that occurs after time t/2.
14. The catheter system of claim 1 wherein the composite energy
pulse has a pulse width having a time t, the composite energy pulse
having a temporal peak that occurs before time t/2.
15. The catheter system of claim 1 wherein the composite energy
pulse has a pulse width having a time t, the composite energy pulse
having a temporal peak that occurs approximately at time t/2.
16. The catheter system of claim 1 wherein the composite energy
pulse has a temporal peak that remains substantially constant over
time.
17. The catheter system of claim 1 wherein the composite energy
pulse includes two temporal peaks that are substantially similar to
one another.
18. The catheter system of claim 1 wherein the composite energy
pulse includes two temporal peaks that are different from one
another.
19. The catheter system of claim 1 wherein the power source
includes (i) a seed source, and (ii) an amplifier, the seed source
emitting a low-power seed pulse, the amplifier being in optical
communication with the seed source, the amplifier increasing the
power of the seed pulse to generate an energy pulse.
20. The catheter system of claim 1 wherein the power source
includes (i) a plurality of seed sources, and (ii) a plurality of
amplifiers, the seed sources each emitting a low-power seed pulse,
the plurality of amplifiers each being in optical communication
with one of the seed sources and each receiving one of the
low-power seed pulses, each amplifier increasing the power of the
seed pulse that is received by the respective amplifier, the
plurality of amplifiers generating the plurality of energy
pulses.
21. The catheter system of claim 1 wherein the power source
includes (i) a plurality of seed sources, and (ii) an amplifier,
the seed sources each emitting a low-power seed pulse, the
amplifier being in optical communication with each of the seed
sources and receiving the low-power seed pulses, the amplifier
increasing the power of each of the seed pulses that is received by
the amplifier, the amplifier generating the plurality of energy
pulses.
22. A method for treating a treatment site within or adjacent to a
vessel wall, the method comprising the steps of: generating a
plurality of energy pulses with a power source; controlling the
power source with a controller so that the plurality of energy
pulses cooperate to produce a composite energy pulse that is sent
to a light guide, the composite energy pulse having a composite
pulse shape; producing light energy that is emitted from the light
guide with the composite energy pulse that is sent to the light
guide; and generating a plasma pulse from the light energy away
from the light guide.
Description
RELATED APPLICATION
[0001] This application claims priority on U.S. Provisional
Application Ser. No. 62/987,060, filed on Mar. 9, 2020. As far as
permitted, the contents of U.S. Provisional Application Ser. No.
62/987,060 are incorporated in their entirety herein by
reference.
BACKGROUND
[0002] Vascular lesions within and adjacent to vessels in the body
can be associated with an increased risk for major adverse events,
such as myocardial infarction, embolism, deep vein thrombosis,
stroke, and the like. Severe vascular lesions can be difficult to
treat and achieve patency for a physician in a clinical
setting.
[0003] Vascular lesions may be treated using interventions such as
drug therapy, balloon angioplasty, atherectomy, stent placement,
vascular graft bypass, to name a few. Such interventions may not
always be ideal or may require subsequent treatment to address the
lesion.
[0004] Creation of a plasma via optical breakdown of an aqueous
solution typically requires a significant amount of energy in a
short amount of time upon which it is converted into a therapeutic
bubble and/or a therapeutic pressure wave. With sufficiently high
energy and short pulse durations, there is potential to damage a
distal end of a light guide used to deliver light energy to
generate the plasma. A means to enhance the conversion efficiency
of the light energy to (plasma) pressure wave and bubble growth
would reduce the required power handling requirements of the
optical delivery system. Therefore, less input energy would be
required for an equivalent therapy while minimizing potential
damage to the light guide.
[0005] Creation of the plasma near the distal end of a small
diameter light guide as in the case of aqueous optical breakdown as
one method for an intravascular lithotripsy catheter has the
potential for self-damage due to its proximity to the plasma
creation and/or the pressure wave, high plasma temperatures, and
waterjet from collapse of the bubble, as non-exclusive
examples.
SUMMARY
[0006] The present invention is directed toward a catheter system
for placement within a blood vessel having a vessel wall. The
catheter system can be used for treating a treatment site within or
adjacent to the vessel wall. In various embodiments, the catheter
system includes a power source, a controller, and a light guide.
The power source generates a plurality of energy pulses. The
controller controls the power source so that the plurality of
energy pulses cooperate to produce a composite energy pulse having
a composite pulse shape. The light guide receives the composite
energy pulse. The light guide emits light energy in a direction
away from the light guide to generate a plasma pulse away from the
light guide.
[0007] In some embodiments, the power source is a laser.
[0008] In certain embodiments, the light guide is an optical
fiber.
[0009] In some embodiments, the catheter system further includes an
inflatable balloon that encircles a distal end of the light
guide.
[0010] In certain embodiments, each of the plurality of energy
pulses are sub-millisecond pulses.
[0011] In some embodiments, each of the energy pulses has a pulse
width, and the energy pulses are added to one another so that the
composite energy pulse has a pulse width that is longer than the
pulse width of any one of the energy pulses.
[0012] In certain embodiments, at least two of the plurality of
energy pulses have the same wavelength as one another.
[0013] In some embodiments, at least one of the plurality of energy
pulses has a wavelength that is different from the other energy
pulses.
[0014] In certain embodiments, at least two of the plurality of
energy pulses have pulse widths that are the same as one
another.
[0015] In some embodiments, at least two of the plurality of energy
pulses have pulse widths that are different from one another.
[0016] In certain embodiments, at least two of the plurality of
energy pulses have light energy that is the same as one
another.
[0017] In some embodiments, at least two of the plurality of energy
pulses have light energy is different from one another.
[0018] In various embodiments, the plurality of energy pulses
combine to generate one continuous plasma pulse away from the
distal end of the light guide.
[0019] In certain embodiments, the composite energy pulse has a
pulse amplitude that increases over time.
[0020] In some embodiments, the composite energy pulse has a pulse
amplitude that decreases over time.
[0021] In certain embodiments, the composite energy pulse has a
pulse width having a time t, the composite energy pulse having a
temporal peak that occurs after time t/2.
[0022] In various embodiments, the composite energy pulse has a
pulse width having a time t, the composite energy pulse having a
temporal peak that occurs before time t/2.
[0023] In certain embodiments, the composite energy pulse has a
pulse width having a time t, the composite energy pulse having a
temporal peak that occurs approximate at time t/2.
[0024] In some embodiments, the composite energy pulse has a
temporal peak that remains substantially constant over time.
[0025] In certain embodiments, the composite energy pulse generates
a plurality of plasma pulses away from the distal end of the light
guide. In some such embodiments, the plurality of plasma pulses are
generated at different times from one another.
[0026] In some embodiments, the composite energy pulse includes two
temporal peaks that are substantially similar to one another. Still
further, or in the alternative, in certain embodiments, the
composite energy pulse includes two temporal peaks that are
different from one another.
[0027] In certain embodiments, the composite energy pulse has a
pulse amplitude that generally increases over time. In other
embodiments, the composite energy pulse has a pulse amplitude that
generally decreases over time.
[0028] In some embodiments, the composite energy pulse has a pulse
width having a time t, the composite energy pulse having a temporal
peak that occurs after time t/2. Alternatively, in other
embodiments, the composite energy pulse has a pulse width having a
time t, the composite energy pulse having a temporal peak that
occurs before time t/2. Still alternatively, in still other
embodiments, the composite energy pulse has a pulse width having a
time t, the composite energy pulse having a temporal peak that
occurs approximately at time t/2. Further, in some such
embodiments, the composite energy pulse has a temporal peak that
remains substantially constant over time.
[0029] In certain embodiments, the light guide has a distal end,
and the catheter system is configured to generate a pre-bubble at a
distal end of the light guide. In some such embodiments, the
composite energy pulse is configured to generate the pre-bubble at
a distal end of the light guide. In one such embodiment, the
pre-bubble is generated by electrolysis. In another such
embodiment, the pre-bubble is generated by using a resistive
heater. In still another such embodiment, the pre-bubble is
generated with a fluid that is delivered to near the distal end of
the light guide.
[0030] In some embodiments, the controller can control a timing of
the composite energy pulse relative to a start of the generation of
the pre-bubble. For example, in certain such embodiments, the
composite energy pulse is generated greater than approximately 1 ns
and less than approximately 100 ms after a start of the generation
of the pre-bubble. In other such embodiments, the composite energy
pulse is generated greater than approximately 100 ns and less than
approximately 1 ms after a start of the generation of the
pre-bubble. In still other such embodiments, the composite energy
pulse is generated greater than approximately 1 .mu.s and less than
approximately 10 ms after a start of the generation of the
pre-bubble. In yet other such embodiments, the composite energy
pulse is generated greater than approximately 5 .mu.s and less than
approximately 500 .mu.s after a start of the generation of the
pre-bubble. In still yet other such embodiments, the composite
energy pulse is generated approximately 50 .mu.s after a start of
the generation of the pre-bubble.
[0031] In certain embodiments, the power source includes (i) a seed
source, and (ii) an amplifier, the seed source emitting a low-power
seed pulse, the amplifier being in optical communication with the
seed source, the amplifier increasing the power of the seed pulse
to generate an energy pulse.
[0032] In some embodiments, the power source includes (i) a
plurality of seed sources, and (ii) a plurality of amplifiers, the
seed sources each emitting a low-power seed pulse, the plurality of
amplifiers each being in optical communication with one of the seed
sources and each receiving one of the low-power seed pulses, each
amplifier increasing the power of the seed pulse that is received
by the respective amplifier, the plurality of amplifiers generating
the plurality of energy pulses.
[0033] In certain embodiments, the power source includes (i) a
plurality of seed sources, and (ii) an amplifier, the seed sources
each emitting a low-power seed pulse, the amplifier being in
optical communication with each of the seed sources and receiving
the low-power seed pulses, the amplifier increasing the power of
each of the seed pulses that is received by the amplifier, the
amplifier generating the plurality of energy pulses.
[0034] In various embodiments, the catheter system further includes
a hydrophobic material that is positioned near a distal end of the
light guide.
[0035] In certain embodiments, the catheter system further includes
a hydrophobic material that is positioned on a distal end of the
light guide.
[0036] In some embodiments, the catheter system further includes a
nano surface that is positioned near a distal end of the light
guide.
[0037] In certain embodiments, the catheter system further includes
a nano surface that is positioned on a distal end of the light
guide.
[0038] In some embodiments, the nano surface is textured.
[0039] In certain applications, the present invention is also
directed toward a method for treating a treatment site within or
adjacent to a vessel wall, the method including the steps of:
generating a plurality of energy pulses with a power source;
controlling the power source with a controller so that the
plurality of energy pulses cooperate to produce a composite energy
pulse that is sent to a light guide, the composite energy pulse
having a composite pulse shape; producing light energy that is
emitted from the light guide with the composite energy pulse that
is sent to the light guide; and generating a plasma pulse from the
light energy away from the light guide.
[0040] This summary is an overview of some of the teachings of the
present application and is not intended to be an exclusive or
exhaustive treatment of the present subject matter. Further details
are found in the detailed description and appended claims. Other
aspects will be apparent to persons skilled in the art upon reading
and understanding the following detailed description and viewing
the drawings that form a part thereof, each of which is not to be
taken in a limiting sense. The scope herein is defined by the
appended claims and their legal equivalents.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] The novel features of this invention, as well as the
invention itself, both as to its structure and its operation, will
be best understood from the accompanying drawings, taken in
conjunction with the accompanying description, in which similar
reference characters refer to similar parts, and in which:
[0042] FIG. 1 is a schematic cross-sectional view of a catheter
system having features of the present invention in accordance with
various embodiments herein;
[0043] FIG. 2A is a simplified schematic diagram illustrating a
first embodiment of a portion of the catheter system that generates
a plurality of overlapping energy pulses that are sent to a light
guide to generate a plasma pulse;
[0044] FIG. 2B is a simplified schematic diagram illustrating
another embodiment of a portion of the catheter system that
generates a plurality of non-overlapping energy pulses that are
sent to the light guide to generate the plasma pulse;
[0045] FIG. 3A is a simplified schematic diagram illustrating an
embodiment of a portion of the catheter system that generates a
plurality of overlapping energy pulses that are sent to the light
guide to generate the plurality of plasma pulses;
[0046] FIG. 3B is a simplified schematic diagram illustrating
another embodiment of a portion of the catheter system that
generates a plurality of non-overlapping energy pulses that are
sent to the light guide to generate the plasma pulse;
[0047] FIG. 4A is a simplified graph illustrating one embodiment of
a composite energy pulse having a composite pulse shape;
[0048] FIG. 4B is a simplified graph illustrating another
embodiment of the composite energy pulse having another composite
pulse shape;
[0049] FIG. 4C is a simplified graph illustrating yet another
embodiment of the composite energy pulse having another composite
pulse shape;
[0050] FIG. 5A is a simplified graph illustrating an embodiment of
the composite energy pulse having another composite pulse
shape;
[0051] FIG. 5B is a simplified graph illustrating another
embodiment of the composite energy pulse having another composite
pulse shape;
[0052] FIG. 5C is a simplified graph illustrating yet another
embodiment of the composite energy pulse having another composite
pulse shape;
[0053] FIG. 5D is a simplified graph illustrating still another
embodiment of the composite energy pulse having another composite
pulse shape;
[0054] FIG. 5E is a simplified graph illustrating another
embodiment of the composite energy pulse having another composite
pulse shape;
[0055] FIG. 5F is a simplified graph illustrating but another
embodiment of the composite energy pulse having another composite
pulse shape;
[0056] FIG. 6A is a simplified schematic diagram illustrating an
embodiment of a portion of the catheter system that generates a
pre-bubble;
[0057] FIG. 6B is a simplified schematic diagram illustrating
another embodiment of a portion of the catheter system that
generates the pre-bubble;
[0058] FIG. 6C is a simplified schematic diagram illustrating yet
another embodiment of a portion of the catheter system that
generates the pre-bubble; and
[0059] FIG. 6D is a simplified schematic diagram illustrating still
another embodiment of a portion of the catheter system that
generates the pre-bubble.
[0060] While embodiments are susceptible to various modifications
and alternative forms, specifics thereof have been shown by way of
example and drawings, and will be described in detail. It should be
understood, however, that the scope herein is not limited to the
particular aspects described. On the contrary, the intention is to
cover modifications, equivalents, and alternatives falling within
the spirit and scope herein.
DESCRIPTION
[0061] Treatment of vascular lesions can reduce major adverse
events or death in affected subjects. As referred to herein, a
major adverse event is one that can occur anywhere within the body
due to the presence of a vascular lesion (also sometime referred to
herein as a "treatment site"). Major adverse events can include,
but are not limited to, major adverse cardiac events, major adverse
events in the peripheral or central vasculature, major adverse
events in the brain, major adverse events in the musculature, or
major adverse events in any of the internal organs.
[0062] As used herein, the treatment site can include a vascular
lesion such as a calcified vascular lesion or a fibrous vascular
lesion (hereinafter sometimes referred to simply as a "lesion" or
"treatment site"), typically found in a blood vessel and/or a heart
valve. Plasma formation can initiate a pressure wave and can
initiate the rapid formation of one or more bubbles that can
rapidly expand to a maximum size and then dissipate through a
cavitation event that can also launch a pressure wave upon
collapse. The rapid expansion of the plasma-induced bubbles can
generate one or more pressure waves within a balloon fluid and
thereby impart pressure waves upon the treatment site. The pressure
waves can transfer mechanical energy through an incompressible
balloon fluid to a treatment site to impart a fracture force on the
lesion. Without wishing to be bound by any particular theory, it is
believed that the rapid change in balloon fluid momentum upon a
balloon wall of the inflatable balloon that is in contact with or
positioned near the lesion is transferred to the lesion to induce
fractures in the lesion.
[0063] Those of ordinary skill in the art will realize that the
following detailed description of the present invention is
illustrative only and is not intended to be in any way limiting.
Other embodiments of the present invention will readily suggest
themselves to such skilled persons having the benefit of this
disclosure. Additionally, other methods of delivering energy to the
lesion can be utilized, including, but not limited to, electric
current induced plasma generation. Reference will now be made in
detail to implementations of the present invention as illustrated
in the accompanying drawings.
[0064] In the interest of clarity, not all of the routine features
of the implementations described herein are shown and described. It
will, of course, be appreciated that in the development of any such
actual implementation, numerous implementation-specific decisions
must be made in order to achieve the developer's specific goals,
such as compliance with application-related and business-related
constraints, and that these specific goals will vary from one
implementation to another and from one developer to another.
Moreover, it is appreciated that such a development effort might be
complex and time-consuming, but would nevertheless be a routine
undertaking of engineering for those of ordinary skill in the art
having the benefit of this disclosure.
[0065] As used herein, the terms "intravascular lesion", "vascular
lesion" and "treatment site" are used interchangeably unless
otherwise noted. As such, the intravascular lesions and/or the
vascular lesions are sometimes referred to herein simply as
"lesions" and can include lesions located at or near blood vessels
or heart valves.
[0066] It is appreciated that the catheter systems herein can
include many different forms and/or configurations other than those
specifically shown and/or described herein. Referring now to FIG.
1, a schematic cross-sectional view is shown of a catheter system
in accordance with various embodiments herein. A catheter system
100 is suitable for imparting pressure to induce fractures in a
treatment site within or adjacent a vessel wall of a blood vessel
and/or a heart valve. In the embodiment illustrated in FIG. 1, the
catheter system 100 can include one or more of a catheter 102, one
or more light guides 122, a controller 123, a power source 124, a
manifold 136 and a fluid pump 138.
[0067] The catheter 102 includes an inflatable balloon 104
(sometimes referred to herein as "balloon"). The catheter 102 is
configured to move to a treatment site 106 within or adjacent to a
blood vessel 108. The treatment site 106 can include a treatment
site such as a calcified vascular lesion, for example.
Additionally, or in the alternative, the treatment site 106 can
include a vascular lesion such as a fibrous vascular lesion.
[0068] The catheter 102 can include the balloon 104, a catheter
shaft 110 and a guidewire 112. The balloon can be coupled to the
catheter shaft 110. The balloon can include a balloon proximal end
104P and a balloon distal end 104D. The catheter shaft 110 can
extend between a shaft proximal end 114 and a shaft distal end 116.
The catheter shaft 110 can include a guidewire lumen 118 which is
configured to move over the guidewire 112. The catheter shaft 110
can also include an inflation lumen (not shown). In some
embodiments, the catheter 102 can have a distal end opening 120 and
can accommodate and be moved over and/or along the guidewire 112 so
that the balloon 104 is positioned at or near the treatment site
106.
[0069] The catheter shaft 110 of the catheter 102 can encircle one
or more light guides 122 (only one light guide 122 is illustrated
in FIG. 1 for clarity) in optical communication with a power source
124. The light guide 122 can be at least partially disposed along
and/or within the catheter shaft 110 and at least partially within
the balloon 104. In various embodiments, the light guide 122 can be
an optical fiber and the power source 124 can be a laser. The power
source 124 can be in optical communication with the light guide
122. In some embodiments, the catheter shaft 110 can encircle
multiple light guides such as a second light guide, a third light
guide, etc.
[0070] The balloon 104 can include a balloon wall 130. The balloon
104 can expand from a collapsed configuration suitable for
advancing at least a portion of the catheter shaft 102 through a
patient's vasculature to an expanded configuration suitable for
anchoring the catheter 102 into position relative to the treatment
site 106.
[0071] The controller 123 can control the power source 124 so that
the power source can generate one or more energy pulses 242A, 242B,
342A, 342B (illustrated in FIGS. 2A-3B, for example) as provided in
greater detail herein. The controller 123 may also perform other
relevant functions to control operation of the catheter 102.
[0072] The power source 124 of the catheter system 100 can be
configured to provide one or more sub-millisecond energy pulses
that are received by the light guide 122. As provided in greater
detail herein, in various embodiments, the energy pulses can
combine or otherwise cooperate to produce a composite energy pulse
having a composite pulse shape (not shown in FIG. 1) that is then
received by the light guide 122. The light guide 122 acts as a
conduit for light energy that is generated by the composite energy
pulse. In certain embodiments, the power source 124 can include one
or more seed sources 126 and one or more amplifiers 128. Each
amplifier 128 can be in optical communication with at least one of
the seed sources 126. The seed source(s) 126 can each emit a
low-power seed pulse. The amplifier 128 can increase the power of
the seed pulse to generate the energy pulse. In one embodiment, the
power source can include one seed source 126 and one amplifier 128.
Alternatively, the power source 124 can include a plurality of seed
sources 126 and one amplifier 128. Still alternatively, the power
source 124 can include a plurality of seed sources 126 and a
plurality of amplifiers 128.
[0073] The light energy that is generated by the composite energy
pulse is delivered by the light guide 122 to a location within the
balloon 104. The light energy induces plasma formation in the form
of a plasma pulse 134 that occurs in the balloon fluid 132 within
the balloon 104. The plasma pulse 134 causes rapid bubble
formation, and imparts pressure waves upon the treatment site 106.
Exemplary plasma pulses 134 are shown in FIG. 1. The balloon fluid
132 can be a liquid or a gas. As provided in greater detail herein,
the plasma-induced bubbles 134 are intentionally formed at some
distance away from the light guide 122 so that the likelihood of
damage to the light guide is decreased.
[0074] In various embodiments, the sub-millisecond pulses of light
can be delivered to near the treatment site 106 at a frequency of
from at least approximately 1 hertz (Hz) up to approximately 5000
Hz. In some embodiments, the sub-millisecond pulses of light can be
delivered to near the treatment site 106 at a frequency from at
least 30 Hz to 1000 Hz. In other embodiments, the sub-millisecond
pulses of light can be delivered to near the treatment site 106 at
a frequency from at least 10 Hz to 100 Hz. In yet other
embodiments, the sub-millisecond pulses of light can be delivered
to near the treatment site 106 at a frequency from at least 1 Hz to
30 Hz. In some embodiments, the sub-millisecond pulses of light can
be delivered to near the treatment site 106 at a frequency that can
be greater than or equal to 1 Hz, 2 Hz, 3 Hz, 4 Hz, 5 Hz, 6 Hz, 7
Hz, 8 Hz, or 9 Hz, 10 Hz, 20 Hz, 30 Hz, 40 Hz, 50 Hz, 60 Hz, 70 Hz,
80 Hz, 90 Hz, 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500 Hz, 600 Hz, 700
Hz, 800 Hz, 900 Hz, 1000 Hz, 1250 Hz, 1500 Hz, 1750 Hz, 2000 Hz,
2250 Hz, 2500 Hz, 2750 Hz, 3000 Hz, 3250 Hz, 3500 Hz, 3750 Hz, 4000
Hz, 4250 Hz, 4500 Hz, 4750 Hz, or 5000 Hz or can be an amount
falling within a range between any of the foregoing. Alternatively,
the sub-millisecond pulses of light can be delivered to near the
treatment site 106 at a frequency that can be greater than 5000
Hz.
[0075] It is appreciated that the catheter system 100 herein can
include any number of light guides 122 in optical communication
with the power source 124 at the proximal portion 114, and with the
balloon fluid 132 within the balloon 104 at the distal portion 116.
For example, in some embodiments, the catheter system 100 herein
can include from one light guide 122 to five light guides 122. In
other embodiments, the catheter system 100 herein can include from
five light guides to fifteen light guides. In yet other
embodiments, the catheter system 100 herein can include from ten
light guides to thirty light guides. The catheter system 100 herein
can include 1-30 light guides. It is appreciated that the catheter
system 100 herein can include any number of light guides that can
fall within a range, wherein any of the forgoing numbers can serve
as the lower or upper bound of the range, provided that the lower
bound of the range is a value less than the upper bound of the
range. In some embodiments, the catheter system 100 herein can
include greater than 30 light guides.
[0076] The manifold 136 can be positioned at or near the shaft
proximal end 114. The manifold 136 can include one or more proximal
end openings that can receive the one or more light guides, such as
light guide 122, the guidewire 112, and/or an inflation conduit
140. The catheter system 100 can also include the fluid pump 138
that is configured to inflate the balloon 104 with the balloon
fluid 132 and/or deflate the balloon 104 as needed.
[0077] As with all embodiments illustrated and described herein,
various structures may be omitted from the figures for clarity and
ease of understanding. Further, the figures may include certain
structures that can be omitted without deviating from the intent
and scope of the invention.
[0078] FIG. 2A is a simplified schematic diagram illustrating a
first embodiment of a portion of the catheter system 200A that
generates a plurality of overlapping energy pulses 242A. In this
embodiment, the overlapping energy pulses 242A combine and are sent
to a light guide 222A to generate a pre-bubble 244A and a plasma
pulse 246A. The plasma pulse 246A generates pressure waves (not
shown), which then disrupt the calcified lesion at or near the
treatment site 106 (illustrated in FIG. 1). By combining a
plurality of energy pulses 242A in a structured manner, a composite
energy pulse 348A (illustrated in FIG. 3A, for example) is
generated. As provided in greater detail below, in this and other
embodiments, the composite energy pulse 348A can be customized or
otherwise tailored to achieve a specific pre-bubble 244A and/or
plasma pulse 246A.
[0079] In one embodiment, and in the embodiments which follow, the
energy pulses 242A can be substantially similar in shape, amplitude
and/or pulse width (duration). Alternatively, one or more of the
shape, amplitude and/or duration pulse width can be different from
energy pulse 242A to energy pulse 242A. With this design, the
composite energy pulse can be customized in a manner that is
advantageous to generating one or more plasma pulses 246A having
the desired characteristics.
[0080] FIG. 2B is a simplified schematic diagram illustrating a
first embodiment of a portion of the catheter system 200B that
generates a plurality of separate, spaced apart energy pulses 242B.
In this embodiment, the spaced apart energy pulses 242B are sent to
a light guide 222B to generate a pre-bubble 244B and/or a plasma
pulse 246B. The plasma pulse 246B generates pressure waves (not
shown), which then disrupt the calcified lesion at or near the
treatment site 106 (illustrated in FIG. 1). By using a plurality of
energy pulses 242B in a structured manner, a composite energy pulse
348B (illustrated in FIG. 3B, for example) is generated. As
provided in greater detail below, in this and other embodiments,
the composite energy pulse 348B can be customized or otherwise
tailored to achieve a specific pre-bubble 244B and/or plasma pulse
246B.
[0081] FIG. 3A is a simplified schematic diagram illustrating an
embodiment of a portion of the catheter system 300A that generates
a plurality of overlapping energy pulses 342A to produce a
composite energy pulse 348A. The composite energy pulse 348A is
sent to the light guide 322A and can generate one or more plasma
pulses 346A. In this embodiment, the plasma pulses 346A can occur
in relatively close proximity to one another and/or close in time
to one another. In the embodiment illustrated in FIG. 3A, the
plasma pulses 346A occur essentially continuously, e.g. the plasma
pulses 346A are substantially in rapid-fire succession to basically
create one continuous plasma pulse 346A having a longer duration
than any one single plasma pulse 346A. The plasma pulses 346A can
generate pressure waves (not shown), which then disrupt the
calcified lesion at or near the treatment site 106 (illustrated in
FIG. 1).
[0082] In one embodiment, and in the embodiments which follow, the
energy pulses 342A can be substantially similar in shape, amplitude
and/or pulse width (duration). Alternatively, one or more of the
shape, amplitude and/or duration pulse width can be different from
energy pulse 342A to energy pulse 342A.
[0083] FIG. 3B is a simplified schematic diagram illustrating an
embodiment of a portion of the catheter system 300B that generates
a plurality of separate, spaced apart energy pulses 342B to produce
a composite energy pulse 348B. The composite energy pulse 348B is
sent to the light guide 322B and can generate one or more plasma
pulses 346B. In this embodiment, the plasma pulses 346B can have a
greater distance between one another and/or a greater time between
each plasma pulse 346B. The plasma pulses 346B can generate
pressure waves (not shown), which then disrupt the calcified lesion
at or near the treatment site 106 (illustrated in FIG. 1).
[0084] FIG. 4A is a simplified graph illustrating one embodiment of
a composite energy pulse 448A having a pulse width with a duration
of t. In this embodiment, the composite energy pulse 448A was
formed by combining a plurality of energy pulses (illustrated in
FIGS. 2A-2B and FIGS. 3A-3B, for example), as set forth in greater
detail herein. In the embodiment illustrated in FIG. 4A, the
composite energy pulse 448A has a temporal peak 450A (greatest
amplitude) that occurs after time t/2. Further, in this embodiment,
the composite energy pulse 448A has relatively low energy at the
onset, which creates pre-seeding prior to the plasma pulse (not
shown in FIG. 4A). In this embodiment, the composite energy pulse
448A has a greater energy toward the end of the pulse, which
ultimately generates the plasma pulse.
[0085] FIG. 4B is a simplified graph illustrating one embodiment of
a composite energy pulse 448B having a pulse width with a duration
of t. In this embodiment, the composite energy pulse 448B was
formed by combining a plurality of energy pulses (illustrated in
FIGS. 2A-2B and FIGS. 3A-3B, for example), as set forth in greater
detail herein. In the embodiment illustrated in FIG. 4B, the
composite energy pulse 448B has a temporal peak 450B (greatest
amplitude) that occurs before time t/2, resulting in the plasma
pulse (not shown in FIG. 4B). Further, in this embodiment, the
composite energy pulse 448B maintains a relatively high, sustaining
energy after the temporal peak 450B, which can feed the plasma
pulse with a relatively high energy long tail after the temporal
peak 450B.
[0086] FIG. 4C is a simplified graph illustrating one embodiment of
a composite energy pulse 448C having a pulse width with a duration
of t. In this embodiment, the composite energy pulse 448C was
formed by combining a plurality of energy pulses (illustrated in
FIGS. 2A-2B and FIGS. 3A-3B, for example), as set forth in greater
detail herein. In the embodiment illustrated in FIG. 4C, the
composite energy pulse 448C has a temporal peak 450C (greatest
amplitude) that occurs before time t/2, resulting in the plasma
pulse (not shown in FIG. 4C). Further, in this embodiment, the
composite energy pulse 448C maintains a relatively low, sustaining
energy after the temporal peak 450C, which can feed the plasma
pulse with a relatively low energy long tail after the temporal
peak 450C.
[0087] FIGS. 5A-5F illustrate non-exclusive embodiments of certain
representative composite energy pulses that can be generated using
the devices and methods provided herein. It is understood that
these embodiments are not intended to illustrate all possible
composite energy pulses, as doing so would be impossible. Rather,
FIGS. 5A-5F are provided to illustrate that any composite energy
pulse shape is possible using the devices and methods disclosed
herein.
[0088] FIG. 5A is a simplified graph illustrating an embodiment of
the composite energy pulse 548A having one composite pulse shape.
In this embodiment, the composite energy pulse 548A includes two
(or more) spaced apart temporal peaks such as a first temporal peak
550AF and a second temporal peak 550AS. Further, in one embodiment,
the composite energy pulse 548A can have two (or more) separate,
spaced apart pulses including a first pulse 552AF and a second
pulse 552AS, each having a different pulse shape from one another,
although it is understood that the pulse shapes can alternatively
be substantially similar or identical to one another.
[0089] FIG. 5B is a simplified graph illustrating an embodiment of
the composite energy pulse 548B having one composite pulse shape.
In this embodiment, the composite energy pulse 548B includes two
(or more) spaced apart temporal peaks such as a first temporal peak
550BF and a second temporal peak 550BS. Further, in one embodiment,
the composite energy pulse 548B can have two (or more) separate,
spaced apart pulses including a first pulse 552BF and a second
pulse 552BS, each having a different pulse shape from one another,
although it is understood that the pulse shapes can alternatively
be substantially similar or identical to one another.
[0090] FIG. 5C is a simplified graph illustrating an embodiment of
the composite energy pulse 548C having one composite pulse shape.
In this embodiment, the composite energy pulse 548C includes two
(or more) spaced apart temporal peaks such as a first temporal peak
550CF and a second temporal peak 550CS. Further, in one embodiment,
the composite energy pulse 548C can have two (or more) separate,
spaced apart pulses including a first pulse 552CF and a second
pulse 552CS, each having a different pulse shape from one another,
although it is understood that the pulse shapes can alternatively
be substantially similar or identical to one another.
[0091] FIG. 5D is a simplified graph illustrating an embodiment of
the composite energy pulse 548D having one composite pulse shape.
In this embodiment, the composite energy pulse 548D includes two
(or more) spaced apart temporal peaks such as a first temporal peak
550DF and a second temporal peak 550DS. Further, in one embodiment,
the composite energy pulse 548D can have two (or more) separate,
spaced apart pulses including a first pulse 552DF and a second
pulse 552DS, each having a different pulse shape from one another,
although it is understood that the pulse shapes can alternatively
be substantially similar or identical to one another.
[0092] FIG. 5E is a simplified graph illustrating an embodiment of
the composite energy pulse 548E having one composite pulse shape.
In this embodiment, the composite energy pulse 548E includes three
(or more) spaced apart temporal peaks such as a first temporal peak
550EF, a second temporal peak 550ES and a third temporal peak
550ET. Further, in one embodiment, the composite energy pulse 548E
can have three (or more) separate, spaced apart pulses including a
first pulse 552EF, a second pulse 552ES and a third pulse 552ET, so
that at least two of the pulses 552EF, 552ES have different pulse
shapes from one another, although it is understood that the pulse
shapes can alternatively all be substantially similar or identical
to one another, or still alternatively, can be all different from
one another.
[0093] FIG. 5F is a simplified graph illustrating an embodiment of
the composite energy pulse 548F having one composite pulse shape.
In this embodiment, the composite energy pulse 548F includes two
(or more) spaced apart temporal peaks such as a first temporal peak
550FF and a second temporal peak 550FS. Further, in one embodiment,
the composite energy pulse 548F can have two (or more) separate,
spaced apart pulses including a first pulse 552FF and a second
pulse 552FS, each having a different pulse shape from one another,
although it is understood that the pulse shapes can alternatively
be substantially similar or identical to one another.
[0094] FIG. 6A is a simplified schematic diagram illustrating an
embodiment of a portion of the catheter system 600A that generates
a pre-bubble 644A. In this embodiment, the catheter system 600A
includes a catheter shaft 610A, a light guide 622A and a pre-bubble
generator 654A. The pre-bubble generator 654A generates the
pre-bubble 644A to provide a gap between the light guide 622A and a
plasma pulse (not shown in FIG. 6A) that will ultimately be
generated. In one such embodiment, the pre-bubble generator 654A
can include a resistive heater. Alternatively, or in addition, the
pre-bubble generator 654A can include a pair (or more) of
electrolysis electrodes or any other material that would encourage
or promote generation of a pre-bubble 644A at or near a distal end
660A of the light guide 622A. With these designs, damage to the
light guide 622A is inhibited because the plasma pulse does not
occur immediately at or on the light guide 622A, but instead occurs
away from the light guide 622A.
[0095] FIG. 6B is a simplified schematic diagram illustrating
another embodiment of a portion of the catheter system 600B that
generates the pre-bubble 644B. In this embodiment, the catheter
system 600B includes a catheter shaft 610B, a light guide 622B and
a pre-bubble generator 654B. The pre-bubble generator 654B
generates the pre-bubble 644B to provide a gap between the light
guide 622B and a plasma pulse (not shown in FIG. 6B) that will
ultimately be generated. In one such embodiment, the pre-bubble
generator 654B can include a fluid port 656 and a fluid line 658
that is in fluid communication with the fluid port 656. In this
embodiment, a fluid (such as air, in one non-exclusive embodiment)
can be delivered to the fluid port 656 via the fluid line 658,
which can generate the pre-bubble 644B. With this design, damage to
the light guide 622B is inhibited because the plasma pulse does not
occur immediately at the distal end 660B or anywhere on the light
guide 622B, but instead occurs away from the light guide 622B.
[0096] FIG. 6C is a simplified schematic diagram illustrating yet
another embodiment of a portion of the catheter system 600C that
generates the pre-bubble 644C. In this embodiment, the catheter
system 600C includes a catheter shaft 610C, a light guide 622C and
a pre-bubble generator 654C. The pre-bubble generator 654C
generates the pre-bubble 644C to provide a gap between the light
guide 622C and a plasma pulse (not shown in FIG. 6C) that will
ultimately be generated. In one such embodiment, the pre-bubble
generator 654C can include a hydrophobic coating. In this
embodiment, surface tension is created so that the pre-bubble would
self-form due to hydrophobicity forces. Alternatively, or in
addition, the pre-bubble generator 654C can include a nano-textured
surface or any other surface or material that would encourage or
promote generation of a pre-bubble at or near a distal end 660C of
the light guide 622C. In this embodiment, the pre-bubble generator
654C is positioned on the catheter shaft 610C. However, it is
recognized that the pre-bubble generator 654C can be positioned at
or on another structure within the catheter system 600C. With this
design, damage to the light guide 622C is inhibited because the
plasma pulse does not occur immediately at or on the light guide
622C, but instead occurs away from the light guide 622C.
[0097] FIG. 6D is a simplified schematic diagram illustrating still
another embodiment of a portion of the catheter system 600D that
generates the pre-bubble 644D. In this embodiment, the catheter
system 600D includes a catheter shaft 610D, a light guide 622D and
a pre-bubble generator 654D. The pre-bubble generator 654D
generates the pre-bubble 644D to provide a gap between the light
guide 622D and a plasma pulse (not shown in FIG. 6D) that will
ultimately be generated. In one such embodiment, the pre-bubble
generator 654D can include a hydrophobic coating. Alternatively, or
in addition, the pre-bubble generator 654D can include a
nano-textured surface or any other surface or material that would
encourage or promote generation of a pre-bubble at or near a distal
end 660D of the light guide 622D. In this embodiment, the
pre-bubble generator 654D is positioned on the light guide 622D.
However, it is recognized that the pre-bubble generator 654D can be
positioned at or on another structure within the catheter system
600D. With this design, damage to the light guide 622D is inhibited
because the plasma pulse does not occur immediately at or on the
light guide 622D, but instead occurs away from the light guide
622D.
Light Guides
[0098] The light guides illustrated and/or described herein can
include an optical fiber or flexible light pipe. The light guides
illustrated and/or described herein can be thin and flexible and
can allow light signals to be sent with very little loss of
strength. The light guides illustrated and/or described herein can
include a core surrounded by a cladding about its circumference. In
some embodiments, the core can be a cylindrical core or a partially
cylindrical core. The core and cladding of the light guides can be
formed from one or more materials, including but not limited to one
or more types of glass, silica, or one or more polymers. The light
guides may also include a protective coating, such as a polymer. It
is appreciated that the index of refraction of the core will be
greater than the index of refraction of the cladding.
[0099] Each light guide can guide light along its length to a
distal portion having at least one optical window. The light guides
can create a light path as portion of an optical network including
a power source. The light path within the optical network allows
light to travel from one part of the network to another. Either or
both of the optical fiber or the flexible light pipe can provide a
light path within the optical networks herein.
[0100] The light guides illustrated and/or described herein can
assume many configurations about the catheter shaft of the
catheters illustrated and/or described herein. In some embodiments,
the light guides can run parallel to the longitudinal axis of the
catheter shaft of the catheter. In some embodiments, the light
guides can be disposed spirally or helically about the longitudinal
axis of the catheter shaft of the catheter. In some embodiments,
the light guides can be physically coupled to the catheter shaft.
In other embodiments, the light guides can be disposed along the
length of the outer diameter of the catheter shaft. In yet other
embodiments the light guides herein can be disposed within one or
more light guide lumens within the catheter shaft. Various
configurations for the catheter shafts and light guide lumens will
be discussed below.
Power Sources
[0101] The power sources suitable for use herein can include
various types of power sources including lasers and lamps. Suitable
lasers can include short pulse lasers on the sub-millisecond
timescale. In some embodiments, the power source can include lasers
on the nanosecond (ns) timescale. The lasers can also include short
pulse lasers on the picosecond (ps), femtosecond (fs), and
microsecond (us) timescales. It is appreciated that there are many
combinations of laser wavelengths, pulse widths and energy levels
that can be employed to achieve plasma in the balloon fluid of the
catheters illustrated and/or described herein. In various
embodiments, the pulse widths can include those falling within a
range including from at least 10 ns to 200 ns. In some embodiments,
the pulse widths can include those falling within a range including
from at least 20 ns to 100 ns. In other embodiments, the pulse
widths can include those falling within a range including from at
least 1 ns to 5000 ns.
[0102] Exemplary nanosecond lasers can include those within the UV
to IR spectrum, spanning wavelengths of about 10 nanometers to 1
millimeter. In some embodiments, the power sources suitable for use
in the catheter systems herein can include those capable of
producing light at wavelengths of from at least 750 nm to 2000 nm.
In some embodiments, the power sources can include those capable of
producing light at wavelengths of from at least 700 nm to 3000 nm.
In some embodiments, the power sources can include those capable of
producing light at wavelengths of from at least 100 nm to 10
micrometers (.mu.m). Nanosecond lasers can include those having
repetition rates of up to 200 kHz. In some embodiments, the laser
can include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG)
laser. In some embodiments, the laser can include a
neodymium:yttrium-aluminum-garnet (Nd:YAG),
holmium:yttrium-aluminum-garnet (Ho:YAG),
erbium:yttrium-aluminum-garnet (Er:YAG), excimer laser, helium-neon
laser, carbon dioxide laser, as well as doped, pulsed, fiber
lasers.
Pressure Waves
[0103] The catheters illustrated and/or described herein can
generate pressure waves having maximum pressures in the range of at
least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated
by a particular catheter will depend on the power source, the
absorbing material, the bubble expansion, the propagation medium,
the balloon material, and other factors. In some embodiments, the
catheters illustrated and/or described herein can generate pressure
waves having maximum pressures in the range of at least 2 MPa to 50
MPa. In other embodiments, the catheters illustrated and/or
described herein can generate pressure waves having maximum
pressures in the range of at least 2 MPa to 30 MPa. In yet other
embodiments, the catheters illustrated and/or described herein can
generate pressure waves having maximum pressures in the range of at
least 15 MPa to 25 MPa. In some embodiments, the catheters
illustrated and/or described herein can generate pressure waves
having peak pressures of greater than or equal to 1 MPa, 2 MPa, 3
MPa, 4 MPa, 5 MPa, 6 MPa, 7 MPa, 8 MPa, 9 MPa, 10 MPa, 11 MPa, 12
MPa, 13 MPa, 14 MPa, 15 MPa, 16 MPa, 17 MPa, 18 MPa, 19 MPa, 20
MPa, 21 MPa, 22 MPa, 23 MPa, 24 MPa, 25 MPa, 26 MPa, 27 MPa, 28
MPa, 29 MPa, 30 MPa, 31 MPa, 32 MPa, 33 MPa, 34 MPa, 35 MPa, 36
MPa, 37 MPa, 38 MPa, 39 MPa, 40 MPa, 41 MPa, 42 MPa, 43 MPa, 44
MPa, 45 MPa, 46 MPa, 47 MPa, 48 MPa, 49 MPa, or 50 MPa. It is
appreciated that the catheters illustrated and/or described herein
can generate pressure waves having operating pressures or maximum
pressures that can fall within a range, wherein any of the forgoing
numbers can serve as the lower or upper bound of the range,
provided that the lower bound of the range is a value less than the
upper bound of the range.
[0104] Therapeutic treatment can act via a fatigue mechanism or a
brute force mechanism. For a fatigue mechanism, operating pressures
would be about at least 0.5 MPa to 2 MPa, or about 1 MPa. For a
brute force mechanism, operating pressures would be about at least
20 MPa to 30 MPa, or about 25 MPa. Pressures between the extreme
ends of these two ranges may act upon a treatment site using a
combination of a fatigue mechanism and a brute force mechanism.
[0105] The pressure waves described herein can be imparted upon the
treatment site from a distance within a range from at least 0.1
millimeters (mm) to 25 mm extending radially from a longitudinal
axis of a catheter placed at a treatment site. In some embodiments,
the pressure waves can be imparted upon the treatment site from a
distance within a range from at least 10 mm to 20 mm extending
radially from a longitudinal axis of a catheter placed at a
treatment site. In other embodiments, the pressure waves can be
imparted upon the treatment site from a distance within a range
from at least 1 mm to 10 mm extending radially from a longitudinal
axis of a catheter placed at a treatment site. In yet other
embodiments, the pressure waves can be imparted upon the treatment
site from a distance within a range from at least 1.5 mm to 4 mm
extending radially from a longitudinal axis of a catheter placed at
a treatment site. In some embodiments, the pressure waves can be
imparted upon the treatment site from a range of at least 2 MPa to
30 MPa at a distance from 0.1 mm to 10 mm. In some embodiments, the
pressure waves can be imparted upon the treatment site from a range
of at least 2 MPa to 25 MPa at a distance from 0.1 mm to 10 mm. In
some embodiments, the pressure waves can be imparted upon the
treatment site from a distance that can be greater than or equal to
0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9
mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm,
or can be an amount falling within a range between any of the
foregoing.
[0106] It should be noted that, as used in this specification and
the appended claims, the singular forms "a," "an," and "the"
include plural referents unless the content and/or context clearly
dictates otherwise. It should also be noted that the term "or" is
generally employed in its sense including "and/or" unless the
content or context clearly dictates otherwise.
[0107] It should also be noted that, as used in this specification
and the appended claims, the phrase "configured" describes a
system, apparatus, or other structure that is constructed or
configured to perform a particular task or adopt a particular
configuration. The phrase "configured" can be used interchangeably
with other similar phrases such as arranged and configured,
constructed and arranged, constructed, manufactured and arranged,
and the like.
[0108] As used herein, the recitation of numerical ranges by
endpoints shall include all numbers subsumed within that range,
inclusive (e.g., 2 to 8 includes 2, 2.1, 2.8, 5.3, 7, 8, etc.).
[0109] It is recognized that the figures shown and described are
not necessarily drawn to scale, and that they are provided for ease
of reference and understanding, and for relative positioning of the
structures.
[0110] The headings used herein are provided for consistency with
suggestions under 37 CFR 1.77 or otherwise to provide
organizational cues. These headings shall not be viewed to limit or
characterize the invention(s) set out in any claims that may issue
from this disclosure. As an example, a description of a technology
in the "Background" is not an admission that technology is prior
art to any invention(s) in this disclosure. Neither is the
"Summary" or "Abstract" to be considered as a characterization of
the invention(s) set forth in issued claims.
[0111] The embodiments described herein are not intended to be
exhaustive or to limit the invention to the precise forms disclosed
in the following detailed description. Rather, the embodiments are
chosen and described so that others skilled in the art can
appreciate and understand the principles and practices. As such,
aspects have been described with reference to various specific and
preferred embodiments and techniques. However, it should be
understood that many variations and modifications may be made while
remaining within the spirit and scope herein.
[0112] It is understood that although a number of different
embodiments of the catheter systems have been illustrated and
described herein, one or more features of any one embodiment can be
combined with one or more features of one or more of the other
embodiments, provided that such combination satisfies the intent of
the present invention.
[0113] While a number of exemplary aspects and embodiments of the
catheter systems have been discussed above, those of skill in the
art will recognize certain modifications, permutations, additions
and sub-combinations thereof. It is therefore intended that the
following appended claims and claims hereafter introduced are
interpreted to include all such modifications, permutations,
additions and sub-combinations as are within their true spirit and
scope, and no limitations are intended to the details of
construction or design herein shown.
* * * * *